Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies

Part of paid clinical trials in Lake Success, New York.

Sponsor
Northwell Health
Study ID
NCT05134311
Status
Recruiting
Apply to this trial

Conditions

  • PAD - Peripheral Arterial Disease
  • Vascular Diseases
  • Wounds

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PIUR tUS Imaging System — DEVICE
    PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging.

Study Details

The ability to have a visual aid to depict areas of vascular disease that are affecting the patient's health can help in patient comprehension of the problem. This comprehension can lead to better understanding of the issue and increase patient compliance to treatment. The hand drawn sketch produced by the ultrasound technologist provides an inadequate visualization of the vascular insufficiency that is causing the patient's symptoms. PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging. This system will provide a low cost and reproducible imaging solution that will be an effective educational tool for people with vascular disease.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3D-US
    These subjects will have a 3D rendering of their vascular testing shown to them.
  • No Intervention: Standard US
    These subjects will be shown a hand drawn sketch of the results of the vascular testing.

Primary Outcome Measure

30 Day re-admission [ Time Frame: 30 Days after imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health Comprehensive Wound CenterLake SuccessNew York11042
Alisha Oropallo, MD
[email protected]
516-233-3780
Amit Rao, MD
[email protected]
5162333671

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By research site
Northwell Health Comprehensive Wound Center· Lake Success, NY

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